- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06976294
- Original Trial
The Effects of Cognitive Behavioral Approach-Based Psychoeducation on Caregivers of Alzheimer's Patients
May 15, 2025 updated by: Pınar Sevda Bozkurt, Pamukkale University
The Effect of Cognitive Behavioral Approach-Based Psychoeducation on Post-Traumatic Growth, Psychological Resilience, and Ruminative Thoughts in Primary Caregivers of Individuals Diagnosed With Alzheimer's Disease
Alzheimer's disease is a progressive and chronic neurocognitive disorder.
Individuals who assume the role of primary caregivers and are responsible for meeting the care needs of the patient often develop serious health problems over time.
It is particularly important to assess the psychological resilience of those who struggle to manage the caregiving process, to identify ruminative thoughts developed in response to negative experiences, and ultimately to determine the presence of post-traumatic growth.
Cognitive Behavioral Therapy (CBT)-based psychoeducational interventions are highly effective in the holistic assessment and support of primary caregivers.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Alzheimer's disease is a progressive and chronic neurocognitive disorder characterized by the deterioration of higher-level cortical functions, leading to cognitive decline, neuropsychiatric behavioral changes, and a reduced ability to perform daily activities.
As the disease progresses, patients gradually lose functional abilities, resulting in an increased demand for care.
Primary caregivers, who are directly responsible for meeting these care needs, often face significant emotional, physical, social, and financial burdens.
Providing long-term care to elderly individuals is a major source of chronic stress and can exceed caregivers' coping capacities.
In this context, psychological resilience serves as a critical protective factor.
Interventions that enhance the resilience of caregivers supporting individuals with chronic mental illness are essential for caregiver empowerment.
Caregivers with low resilience are more prone to maladaptive coping mechanisms, such as ruminative thinking.
Rumination can intensify psychological distress when negative thoughts interact with depressive mood states during the processing of traumatic experiences.
However, not all traumatic experiences lead to negative outcomes; in some cases, individuals may grow stronger and experience positive psychological changes, known as post-traumatic growth (PTG).
PTG refers to the positive transformation that can emerge from the struggle with highly challenging life circumstances.
The psychological toll of caregiving highlights the importance of supportive psychological interventions.
Psychoeducational programs based on Cognitive Behavioral Therapy (CBT) offer a comprehensive approach by addressing the needs of caregivers while also considering both the patients and the broader family systems.
This study aims to examine the effects of CBT-based psychoeducation on post-traumatic growth, psychological resilience, and ruminative thinking among primary caregivers of individuals diagnosed with Alzheimer's disease.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: PINAR SEVDA BOZKURT
- Phone Number: 05397071799
- Email: pinargul1694@gmail.com
Study Contact Backup
- Name: GÜLAY TAŞDEMİR, Associate Professor Doctor
- Phone Number: 05386418674
- Email: gyigitoglu@pau.edu.tr
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Aged 18 years or older
- Willing to participate in the study
- A member of the Denizli Alzheimer Association
- At least a primary school graduate
- Able to communicate effectively
- Providing primary care to an individual diagnosed with Alzheimer's for at least one year
- Providing primary care to a patient diagnosed with moderate to advanced stage Alzheimer's
- Serving as a primary caregiver for at least six months
Exclusion Criteria:
- Primary caregivers who have participated in any psychoeducation group
- Caregivers who have been diagnosed with any mental health disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Primary Caregivers of Individuals Diagnosed with Alzheimer's (Experimental group)
|
The 'Socio-Demographic Characteristics Form', the 'Post-Traumatic Growth Inventory', the 'Psychological Resilience Scale for Adults', and the 'Event-Related Rumination Inventory' will be administered to individuals in both the intervention and control groups.
No intervention will be applied to the control group.
For the intervention group, psychoeducation groups based on the cognitive behavioral approach will be formed for the primary caregivers.
Eight face-to-face sessions, each lasting 60 to 90 minutes, will be conducted
|
|
No Intervention: Primary Caregivers of Individuals Diagnosed with Alzheimer's (Control group)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Socio-Demographic Characteristics Form
Time Frame: two weeks
|
It consists of questions covering descriptive characteristics of the primary caregivers of Alzheimer's patients, such as age, gender, education level, degree of relationship with the patient, and the duration of caregiving.
|
two weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-Traumatic Growth Inventory
Time Frame: two weeks
|
The inventory consists of 21 items and five factors.
It is a self-report scale in a five-point Likert format, scored between '0 (I did not experience this change)' and '5 (I experienced this change to a very great degree)'.
The total score that can be obtained from the inventory ranges from 0 to 105.
Higher scores indicate greater post-traumatic growth
|
two weeks
|
|
Psychological Resilience Scale for Adults
Time Frame: two weeks
|
The scale consists of a total of 33 items.
Each item presents two opposing statements regarding a specific situation, and respondents are asked to mark the option that best reflects their level of agreement or appropriateness.
|
two weeks
|
|
Event-Related Rumination Inventory
Time Frame: two weeks
|
The inventory consists of 20 items and is divided into two sections of 10 items each, assessing two types of rumination: 'intrusive' and 'deliberate'.
It is structured as a 4-point Likert scale, where a score of 0 indicates 'never' and a score of 3 indicates 'often.
|
two weeks
|
|
Beck Depression Inventory
Time Frame: two weeks
|
It is a 21-item assessment scale that measures depressive symptoms and characteristic attitudes.
It uses a 4-point Likert-type format, with each item scored between 0 and 3.
The total score ranges from 0 to 63.
|
two weeks
|
|
Beck Anxiety Inventory
Time Frame: two weeks
|
It is a 21-item assessment scale.
Each item includes four options scored from 0 to 3. The total score from the 21 items ranges from 0 to 63, with higher scores indicating increased anxiety symptoms.
|
two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 15, 2025
Primary Completion (Estimated)
December 20, 2025
Study Completion (Estimated)
December 31, 2025
Study Registration Dates
First Submitted
May 9, 2025
First Submitted That Met QC Criteria
May 15, 2025
First Posted (Actual)
May 16, 2025
Study Record Updates
Last Update Posted (Actual)
May 16, 2025
Last Update Submitted That Met QC Criteria
May 15, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAU-SBF-PSB-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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